RECRUITING

Delayed Blood Stem Transplantation in HLA Matched Kidney Transplant Recipients to Eliminate Immunosuppressive Drugs.

Conditions

Immune Tolerance Kidney Transplantation Blood Stem Cell Transplantation

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

The study will determine whether patients with functioning Human Leukocyte Antigen (HLA) matched kidney transplants for at least one year and who want to discontinue immunosuppressive drugs can be treated with Total Lymphoid Irradiation (TLI) and rabbit Anti-Thymocyte Globulin (rATG) and an HLA matched donor hematopoietic progenitor cell infusion such that their drugs are successfully withdrawn while maintaining normal renal function.

Official Title

Total Lymphoid Irradiation, Anti-Thymocyte Globulin and Purified Donor CD34+ and T-cell Transfusion to Withdraw Immunosuppressive Drugs From Recipients of a Previous HLA Matched Living Donor Kidney Transplantation .

Quick Facts

Study Start:2018-09-13

Study Completion:2025-10-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT03591302

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion Criteria
1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection. 2. Patients who agree to participate in the study and sign an Informed Consent 3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent. 4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford. 5. Patients who have no known contraindication to the administration of rabbit ATG or radiation 6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.	1. Known allergy to ATG or a known allergy to rabbit proteins. 2. History of malignancy with the exception of non-melanoma skin malignancies. 3. Pregnant women or nursing mothers. 4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection. 5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (platelet count \< 100,000/mm3) 6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease. 7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.

Inclusion Criteria

Exclusion Criteria

1. All consenting adults of age 18 years and older with previous HLA matched sibling living donor renal transplants who still have their HLA- matched kidney donor available, and who have no history of acute or chronic rejection.
2. Patients who agree to participate in the study and sign an Informed Consent
3. The HLA-matched donor meets the Stanford Bone Marrow Transplant criteria for stem cell donation, agrees to participate and has signed an Informed Consent.
4. The pair is confirmed to be HLA-matched (2 haplo type match) as determined by the histocompatibility laboratory at Stanford.
5. Patients who have no known contraindication to the administration of rabbit ATG or radiation
6. Males and females of reproductive potential who agree to practice a reliable form of contraception for at least 18 months post transplant.

1. Known allergy to ATG or a known allergy to rabbit proteins.
2. History of malignancy with the exception of non-melanoma skin malignancies.
3. Pregnant women or nursing mothers.
4. Serological evidence of HIV, Hepatitis B (HepBsAg+) or Hepatitis C infection.
5. Leukopenia (with a white blood cell count \< 3000/mm3) or thrombocytopenia (platelet count \< 100,000/mm3)
6. Previous history of acute or chronic rejection of the kidney transplant or recurrence of the original disease.
7. Screening kidney biopsy demonstrating acute or chronic rejection, recurrence of original disease or interstitial fibrosis/Tubular Atrophy (IF/TA) score greater than 1.

Contacts and Locations

Study Contact

STEPHAN BUSQUE, MD

CONTACT

6504986189

sbusque@stanford.edu

Stephan Busque, MD,MS

CONTACT

6504986189

sbusque@stanford.edu

Principal Investigator

Samuel Md Strober, MD

STUDY_CHAIR

Stanford University

Study Locations (Sites)

Stanford University Medical Center

Palo Alto, California, 94304

United States

Collaborators and Investigators

Sponsor: Stephan Busque

Samuel Md Strober, MD, STUDY_CHAIR, Stanford University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2018-09-13

Study Completion Date2025-10-01

Study Record Updates

Study Start Date2018-09-13

Study Completion Date2025-10-01

Terms related to this study

Keywords Provided by Researchers

Kidney Transplantation
Blood Stem Cell Transplantation

Additional Relevant MeSH Terms

Immune Tolerance